# K974381: Candela Gentlelase GL Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 10, 1998 after 82 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963094 (1996). 2 ancestors in all.
1,178 later devices descend from it; 5 cite it directly.
0 of 1,181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972767: Candela Gentlelase GL Dermatological Vascular Lesion Laser, Candela Corp. (1997). Cleared while this submission was under review Summary page 1.
- (no number) Candela Dynamic Cooling Device: named in the summary without a submission number

## Most influential descendants
- K990417: Dermacool (1999), 1,062 descendants of its own
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K981351: Candela Gentlelase GL Dermatological Laser (1998), 811 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own

## Indications for use
The Candela Gentlelase GL Dermatology Laser is indicated for the following uses: 1. the photocoagulation of dermatological vascular lesions. The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.

Source page: https://510kreport.com/device/K974381
Methodology: https://510kreport.com/methodology